MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 13 of the bd insyte¿, peripheral iv cannula, bd vialon¿ bio material were damaged, cracked.The following information was provided by the initial reporter, translated from japanese to english: fragility of the short catheter.When checked before use, the tip of the short catheter cracked in 2.Use of an insyte 20g rose 30mm short catheter, reference 381234.We have 1 device affected + 12 others of the same reference and batches affected.The device remains at your disposal for expert appraisal.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current controls, there are outgoing and hourly in-process visual inspections in place to check for catheter damage.No photo/sample was received for further investigation.Root cause could not be determined.
Event or Problem Description
Fragility of the short catheter.When checked before use, the tip of the short catheter cracked in 2.Use of an insyte 20g rose 30mm short catheter, reference (b)(4).We have 1 device affected + 12 others of the same reference and batches affected.The device remains at your disposal for expert appraisal.
Event or Problem Description
Fragility of the short catheter.When checked before use, the tip of the short catheter cracked in 2.Use of an insyte 20g rose 30mm short catheter, reference (b)(4).We have 1 device affected + 12 others of the same reference and batches affected.The device remains at your disposal for expert appraisal.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned actual sample, tip spear was observed on the catheter tip.The assembly process was reviewed.If the catheter tip was torn during the manufacturing process, the defect would be detected and auto rejected by the inline tip spear 100% vision inspection system due to not meeting the tip quality requirement.While challenged with the complaint sample, the vision system was able to reject the sample.From the returned sample also, observed a ¿v-cut¿ on the catheter that matches the shape of the bevel, which could be caused by needle pierced through catheter.Needle pierced through catheter could happen during needle cover removal, if not done carefully.As current controls, there are daily outgoing inspection and hourly in-process inspection in place to check for catheter tip damage and needle pierced through catheter.Unable to establish the actual root cause as the sample was returned without packaging.

• Brand Name: BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17931183
• Report Number: 8041187-2023-00537
• Device Sequence Number: 6368446
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: (01)30382903812234
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 381223
• Device Lot Number: 2317240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 03/27/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 02/07/2024; 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown